Cellular Therapeutics And Regenerative Medicine: Preclinical Assessments For Proof Of Concept And Safety

Posted: October 28, 2012 at 6:44 am

By Thomas Vihtelic, Director, Experimental Therapeutics, MPI Research

Regenerative medicine is attracting significant attention as a medical technology capable of treating what were previously determined to be untreatable diseases. Scientists worldwide are engaged in stem cell research that may enable the repair of damaged heart muscle after a heart attack, restore movement after spinal cord injury, regenerate pancreatic tissue to produce insulin for people with diabetes, and achieve long-sought medical remedies. Animal studies with cell-based therapeutics have demonstrated success, although technological and scientific hurdles remain. Preclinical assessments of cell-based therapies to demonstrate proof of concept and evaluate the risk-benefit ratio for human use present unique challenges requiring expertise and specialized technical capabilities.

This paper presents an overview of stem cell types, their therapeutic risk factors, and preclinical research objectives. The applications of cell-based therapies for selected diseases based on animal models and the qualities to look for when choosing a contract research organization (CRO) for evaluating stem cell-based products are also discussed.

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Cellular Therapeutics And Regenerative Medicine: Preclinical Assessments For Proof Of Concept And Safety

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